Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRiverside University Health System Medical Center

About this trial

This study is evaluating whether Steri-Strips® provide additional benefits when used after cesarean section (C-section) surgery. Steri-Strips are adhesive strips that are commonly placed over a surgical incision to provide support while the wound heals. At our hospital, Steri-Strips are routinely used after C-sections in addition to standard wound closure techniques, although they are not considered part of the standard recommended closure method.

Researchers want to determine whether adding Steri-Strips actually reduces wound complications such as infection, fluid collection under the skin, or reopening of the incision. Previous studies have shown mixed results, with some suggesting little difference in wound healing outcomes while others reported differences in scar appearance. Steri-Strips may also increase costs, add time to the surgery, and occasionally cause skin irritation or allergic reactions.

Participants in this study will be randomly assigned to one of two groups. One group will receive standard cesarean wound closure with Steri-Strips, while the other group will receive standard wound closure without Steri-Strips. Researchers will compare wound healing, complications, patient outcomes, and costs between the two groups.

The goal of this study is to determine whether Steri-Strips improve recovery after cesarean delivery and whether their routine use is beneficial and cost-effective. The findings may help guide future recommendations for cesarean wound care and improve outcomes for patients undergoing C-section delivery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients age 18 years or older

Pregnant patients undergoing cesarean delivery at Riverside University Health System Medical Center (RUHS)

Able and willing to provide informed consent

Disqualifiers

Known allergy or hypersensitivity to Steri-Strip™ materials or adhesives

Inability or unwillingness to provide informed consent

Anticipated inability to complete the 30-day postpartum follow-up evaluation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Steri-Strip™ Skin Closures

    Device

    Application of Steri-Strip adhesive skin closure strips following standard cesarean section wound closure according to a standardized protocol.

  • Standard Cesarean Wound Closure

    Procedure/Surgery

    Standard skin closure performed following cesarean delivery according to institutional practice.

Treatment groups

610 Participants
are divided into 2 treatment groups
Group A: Standard Closure + Steri-StripsExperimental treatment 2 interventions
Group B: Standard Closure AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Cesarean Section Wound Complications

Composite incidence of postoperative wound complications including surgical site infection, wound seroma, and wound separation/dehiscence following cesarean delivery.

Time frame
Within 30 days postpartum

Secondary outcomes

1

Length of Hospital Stay

Duration of hospitalization measured from cesarean delivery until discharge.

Time frame
From cesarean delivery until hospital discharge (up to 7 days)
2

Readmission Related to Wound Complications

Hospital readmission attributable to wound infection, seroma, or wound separation/dehiscence following cesarean delivery.

Time frame
Within 30 days postpartum
3

Cost of Wound Management

Comparison of direct healthcare costs associated with wound closure materials and management of postoperative wound complications between study groups.

Time frame
From cesarean delivery through 30 days postpartum

Other outcomes

Sponsors and contacts

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